Randomized, Double Blinded, Controlled, Two-center Study Assessing the Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
Overview
- Phase
- Phase 2
- Intervention
- ranibizumab and vitrectomy
- Conditions
- Diabetic Retinopathy
- Sponsor
- Attila Vajas
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Efficacy of preoperative intravitreal ranibizumab
- Last Updated
- 12 years ago
Overview
Brief Summary
This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.
Detailed Description
This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.
Investigators
Attila Vajas
MD
University of Debrecen
Eligibility Criteria
Inclusion Criteria
- •male or female 18 or older who have signed an informed consent
- •Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
- •study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
- •study eye vision decrease must be resulted from severe PDR
Exclusion Criteria
- •Active ocular inflammation or infection
- •History of uveitis
- •Uncontrolled glaucoma
- •High myopia
- •Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
- •Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye
- •History of vitrectomy within 60 days preceding Day 1 in the study eye
- •History of intraocular surgery within 30 days preceding Day 1 in the study eye
- •Untreated diabetes mellitus
- •Severe hypertension (systolic pressure higher than 160mmHg)
Arms & Interventions
vitrectomy with ranibizumab
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
Intervention: ranibizumab and vitrectomy
vitrectomy without ranibizumab
Patients receiving sham treatment before vitrectomy as a comparator arm
Intervention: vitrectomy without preoperative ranibizumab
Outcomes
Primary Outcomes
Efficacy of preoperative intravitreal ranibizumab
Time Frame: OP day
Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
Secondary Outcomes
- Change in BCVA.(6 months)
- Effect in anatomical changes.(3 ±1 days after injection)
- Retinal circulation integrity.(Month 1, 3, 6.)
- Safety.(Over 6 months.)